21 CFR § 880.2930 - Apgar timer.

---
identifier: "/us/cfr/t21/s880.2930"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.2930 - Apgar timer."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.2930"
section_name: "Apgar timer."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 880.2930 Apgar timer.

(a) *Identification.* The Apgar timer is a device intended to alert a health care provider to take the Apgar score of a newborn infant.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[63 FR 59718, Nov. 5, 1998, as amended at 90 FR 55986, Dec. 4, 2025]